COVAXIN granted much-awaited WHO approval

WHO's final nod to COVAXIN will now enable travellers fully vaccinated with Covaxin to travel to the United States from November 8. a

Created On: Nov 4, 2021 14:12 IST
Representational Image
Representational Image

The World Health Organisation (WHO) granted its much-awaited Emergency Use Listing (EUL) to India's first indigenously developed COVID-19 vaccine, Covaxin on November 3, 2021. The vaccine has now been added to the growing portfolio of vaccines that have received a go-ahead from WHO for emergency use against COVID-19. 

Following the WHO's EUL Listing approval, Bharat Biotech MD Dr Krishna Ella said in a video, "Today, Covaxin got EUL from WHO. It's a momentous occasion for Indian innovation, entrepreneurship, startup & Indian science. We're grateful to the PM & many respected people who took Covaxin to instill confidence in Indian science."

ICMR DG Dr Balram Bhargava said, "With this, the whole world opens up for us, for sending this vaccine. Now that we have administered a large number of vaccine doses, we will be able to send this absolutely indigenous vaccine to the rest of the world."

Union Health Minister Mansukh Mandaviya thanked WHO for Emergency Use Listing (EUL) to the Made-in-India Covaxin. He said, "This is a sign of a capable leadership. This is the story of Modi Ji's resolve."

WHO Director General Tedros Adhanom Ghebreyesus said, "Glad to see one more vaccine, #Covaxin, being granted WHO emergency use listing. The more products we have to fight #COVID19, the better."

Significance

The WHO EUL Listing will now enable Covaxin to get emergency use approval in other countries as well that haven't yet given it a go-ahead.The countries will now be able to expedite their regulatory approval processes to import and administer Covaxin. 

This also means that UNICEF, GAVI COVAX facility, Pan-American Health Organization (PAHO), will be able to procure Covaxin for distribution to countries worldwide.

The approval will also enable travellers fully vaccinated with Covaxin to travel to the United States from November 8. The US Centers for Disease Control (CDC) acknowledged WHO's EUL listing of India's indigenous vaccine Covaxin on November 3, 2021. 

The US CDC's travel guidance allows all people vaccinated with FDA approved and WHO Emergency Use Listing vaccines to enter the United States. The guidance includes any new vaccine that may be added to either of those lists over time.

Key Highlights

Covaxin has shown 77.8 percent efficacy against symptomatic COVID-19 and 65.2 percent efficacy against the new Delta variant. 

Bharat Biotech has concluded the final analysis of the protection offered by Covaxin against the COVID-19 virus from its Phase 3 trials.

The Covaxin data was reviewed by WHO's Technical Advisory Group and Strategic Advisory Group of Experts on Immunization (SAGE). The strategic advisory group recommended the use of the vaccine in two doses, with a dose interval of four weeks, in all age groups 18 and above.

Background

The WHO panel had earlier south additional clarifications from Bharat Biotech, manufacturer of Covaxin to conduct a final assessment for the global use of the vaccine.

The WHO approval finally came through upon the recommendation of the Technical Advisory Group (TAG) for Emergency Use Listing (TAG-EUL). The group determined that the Covaxin vaccine meets WHO standards for protection against COVID and that benefit of the vaccine far outweighs risks and the vaccine can be used across the world.

The Technical Advisory Group is an independent advisory panel that was convened by WHO to provide recommendations on whether the COVID vaccine should be listed for emergency use under the EUL procedure. The advisory group is made up of regulatory experts from around the world.

However, WHO stated that the available data on vaccination of pregnant women with the Covaxin are insufficient to assess vaccine safety or efficacy in pregnancy and added that studies in pregnant women are planned, including a pregnancy sub-study and a pregnancy registry.

The World Health Organisation has so far granted EUL listing to COVID-19 vaccines of Pfizer-BioNTech, Moderna,  Johnson & Johnson Janssen, AstraZeneca- SK Bio/SII and Sinopharm. 

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